PEG-3350 and Electrolytes
AFFORDABLE PHARMACEUTICALS LLCPEG-3350 and Electrolytes
Approved
Approval ID
f8571cb8-7bdd-43dc-968e-f24362d5fb18
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PEG-3350 and Electrolytes
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6138
Application NumberNDA019011
Product Classification
M
Marketing Category
C73605
G
Generic Name
PEG-3350 and Electrolytes
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2010
FDA Product Classification
INGREDIENTS (5)
SODIUM SULFATE ANHYDROUSActive
Quantity: 22.74 g in 2 L
Code: 36KCS0R750
Classification: ACTIB
SODIUM BICARBONATEActive
Quantity: 6.74 g in 2 L
Code: 8MDF5V39QO
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 5.86 g in 2 L
Code: 451W47IQ8X
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Active
Quantity: 236 g in 2 L
Code: G2M7P15E5P
Classification: ACTIB
POTASSIUM CHLORIDEActive
Quantity: 2.97 g in 2 L
Code: 660YQ98I10
Classification: ACTIB
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 8/23/2010
for Oral Solution
Rx only